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优化脆弱个体参与纵向临床试验的招募、参与和保留率的方法。

Methods to Optimize Recruitment, Participation, and Retention Among Vulnerable Individuals Participating in a Longitudinal Clinical Trial.

机构信息

School of Nursing, University of Maryland, Baltimore, MD

Department of Psychology, University of Kansas, Lawrence, KS.

出版信息

Res Theory Nurs Pract. 2021 Feb 1;35(1):24-49. doi: 10.1891/RTNP-D-19-00039.

Abstract

Low-income and ethnic/racial minority adults do not often participate in research or may face unique barriers when participating in research, which delays and impedes medical advances for this vulnerable population. This article describes in detail the evidenced-based methods used to enhance recruitment, participation, and retention in a clinical trial at a center serving ethnic/racial minorities and low-income individuals. The article details the partnership with a community outreach center and describes the duties and impact of a community liaison to enhance recruitment, participation, and retention in a randomized controlled trial with a 6-month follow-up. Of the 246 individuals initially recruited for screening, 80 did not meet inclusion criteria with the most common reason for disqualification being meeting criteria for substance use disorder ( = 44). One hundred sixty-six participants qualified for participation. The majority of participants identified as African American ( = 127, 77.1%) and reported an annual individual income under $10,000 ( = 121 (74.2%). Forty-five percent of the sample completed the requested number of sessions (i.e., 12). Sixty-three percent of participants completed post intervention assessments and 42% completed 6-month follow-up data collection. The participation and retention numbers in this study appear higher than typical participation and retention rates in longitudinal studies with similar populations. The methods and lessons learned may be useful for other clinical trials that recruit vulnerable populations and wish to enhance participation, engagement, and retention.

摘要

低收入和少数族裔/种族成年人通常不参与研究,或者在参与研究时可能面临独特的障碍,这延迟和阻碍了这个弱势群体的医学进步。本文详细描述了在为少数族裔/种族和低收入人群服务的中心进行临床试验中,用于增强招募、参与和保留率的循证方法。本文详细介绍了与社区外展中心的合作关系,并描述了社区联络人的职责和影响,以增强一项随机对照试验的招募、参与和保留率,该试验有 6 个月的随访。在最初招募进行筛选的 246 人中,有 80 人不符合纳入标准,最常见的不合格原因是符合物质使用障碍标准(=44)。166 名参与者符合参与条件。大多数参与者被确定为非裔美国人(=127,77.1%),并报告个人年收入低于 10,000 美元(=121(74.2%)。样本中有 45%完成了要求的疗程数(即 12 次)。63%的参与者完成了干预后评估,42%完成了 6 个月的随访数据收集。这项研究中的参与和保留率似乎高于类似人群的纵向研究中的典型参与和保留率。这些方法和经验教训可能对其他招募弱势群体并希望增强参与度、参与度和保留率的临床试验有用。

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